Medical Device Manufacturer · US , Fremont , CA

Shockwave Medical, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2016

Recent clearances: Shockwave CS Guide Catheter, Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter, Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

13
Total
13
Cleared
0
Denied

Shockwave Medical, Inc. has 13 FDA 510(k) cleared cardiovascular devices. Based in Fremont, US.

Latest FDA clearance: Jul 2026. Active since 2016.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Shockwave Medical, Inc.

13 devices
1-12 of 13
Filters
All13 Cardiovascular 13